To say this administration is imploding may be an understatement.  This is the second department that has complained about what is going on with the Obama administration.

Susan Wood quit her job as an assistant commissioner for woman’s health at the Food and Drug Administration in 2005 because she thought political, not scientific, forces were delaying efforts to make the Plan B emergency contraceptive available without a prescription. Four years later, she rejoiced when she was present to watch President Barack Obama sign a statement that said decisions in his administration would be based on science, not politics.

Now she says she is beyond disappointed. Obama’s Secretary of Health and Human Services, a member of his cabinet, Wednesday made a new decision to prevent a further expansion of Plan B’s over-the-counter use, this time to adolescents, overruling not only FDA staffers but also the drug agency’s commissioner, Margaret Hamburg. Although the HHS secretary, Kathleen Sebelius, was within her legal authority under the 1938 law that created the FDA, this is the first time a presidential administration has ever publicly overruled the FDA in this manner.

“This is contrary to the scientific integrity memo signed by Obama,” Wood says. “It’s contrary to the whole principal of making decisions based on science and evidence.”

Wood says the decision sets “a terrible precedent for the whole breadth and depth of the FDA” and that the “medical and scientific expertise to make such decisions and recommendations truly resides in the FDA,” not elsewhere in Sebelius’ department. The only silver lining, Wood says, is that by publicly standing up to Sebelius with a letter of protest posted on the FDA’s web site, Hamburg may have prevented the decision from demoralizing rank-and-file FDA staffers.

President Obama asserted yesterday that he “did not get involved in he process” but backed Sebelius’ decision. Whatever the merits of the plan B decision, using Sebelius’ power in this way may tarnish what has been one of the Obama administration’s great, pro-business achievements: Hamburg’s successful transformation of an embattled FDA, scarred and damaged by the controversies over big pharmaceutical industry scandals like Vioxx and Avandia, into an agency that is approving new medicines and a near-record clip and clearly and efficiently deals with new controversies as they crop up.

The question is whether this decision is a one-off, or a change in the way medicines are regulated. Could future negotiations with drug companies be weakened by the fear that the FDA commissioner would be overruled? And even if Sebelius is always going to back up Hamburg on every other regulatory decision, what about future administrations?

David A. Kessler, who headed the FDA between 1990 and 1997, praises the Sebelius and Hamburg for being transparent by airing their disagreement in public. And he says that for many decisions like Plan B, even if they are based on science, reasonable people can disagree. “There’s no scientific textbook where you can look up the answer,” he says. “You can respect people coming out on different sides.” His worry is not about whether 11-year-olds should need a prescription for Plan B, but about what happens in the future if decisions traditionally made by FDA scientists become cabinet-level political issues.

“My concern is just that it’s lousy precedent,” says Kessler. “The last thing you’d want is to have this be seen as precedent so any new drug applicant sees the decision-maker as the secretary. That’s not the way it’s ever worked or should work.”

link:  http://www.forbes.com/sites/matthewherper/2011/12/09/did-the-obama-...